The Raycell X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease according to applicable FDA, AABB, Health Canada, and European guidelines.

The Raycell X-ray Blood Irradiator is also intended for use in the irradiation of intra-operatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis.

Device Description

The Raycell is a self-contained shielded cabinet X-Ray Blood Irradiator. The device consists of a lead shielded chamber containing two vertically opposed x-ray tubes with provision for a sample canister holder between them, dual power supplies and a operator control panel. The operator places the blood products to be irradiated in the canister, opens the drawer, places the canister in the holder, closes the drawer and starts the irradiation cycle at the Operator Panel. The design of this device is substantially equivalent to the predicate device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Raycell Mk2 X-Ray Blood Irradiator. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Raycell, K051065) rather than presenting a clinical study to prove the device meets specific acceptance criteria based on patient outcomes or diagnostic performance.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance with ground truth) are not applicable or not present in this type of regulatory submission.

However, I can extract the information related to the device's technical specifications and safety/effectiveness testing against functional specifications, as this is the "study" referred to in the document.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of quantitative acceptance criteria for clinical performance or diagnostic metrics. Instead, it focuses on demonstrating that the modified aspects of the Raycell Mk2 are equivalent or better than the predicate device's performance in terms of safety and technical functionality.

Acceptance Criteria (General)	Reported Device Performance
Safety:	Safety:
Compliance with IEC 60601-1-2 (EMC)	Complies with IEC 60601-1-2: Edition 3.0 2007-03
Compliance with IEC 60601-1 (Basic Safety & Essential Performance)	Complies with IEC 60601-1: Edition 3.0 2005 + CORR. 1 (2006) + CORR. 2 (2007)
External radiation fields (compared to predicate)	Decreased from the predicate design.
Electrical interlocks	Maintained.
New electro-mechanical safety interlock (for sliding drawer)	Added to prevent opening during x-ray generation.
Effectiveness/Functionality:	Effectiveness/Functionality:
Irradiate blood and blood products (to inactivate T-lymphocytes)	Uses the same x-ray tubes and high voltage generators as the predicate. Operates at a 25% higher power (4kW instead of 3.2kW).
Software control system	No changes to the control system software from the predicate design.
Dose delivered	Not explicitly stated, but the purpose of the device (inactivation of T-lymphocytes) implies it delivers a sufficient dose. The optional digital traceability has no impact on radiation times or dose delivered.
Ability to accommodate varying sample sizes	Available in 3.5L or 2L sample canister configurations (predicate was 1.5L).
Improved manufacturability and service access	Shielded irradiation chamber modified to improve manufacturability and access for service and maintenance.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified as a number of patient cases or blood samples in the context of a clinical study. The "test set" refers to the device itself undergoing engineering and safety validation.
Data Provenance: The testing was likely conducted in a controlled laboratory or manufacturing environment by the manufacturer (Best Theratronics, Canada). It is not clinical data from patients or blood products in a real-world setting, but rather engineering verification and validation testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As this is an engineering and safety validation of an irradiator, not a diagnostic or AI-based device, there were no clinical experts establishing "ground truth" for patient data. The "ground truth" here would be the physical and electrical parameters of the device meeting established engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No clinical adjudication method was used. The device's performance was evaluated against technical specifications and regulatory standards by engineers and quality assurance personnel.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is an X-ray blood irradiator, not an AI-assisted diagnostic device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a standalone medical device (X-ray blood irradiator). The "standalone performance" refers to the device's technical operation as described in the "Safety & Effectiveness" section against functional specifications and regulatory standards. There is no "algorithm only" performance to evaluate in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's acceptable performance was based on engineering specifications, international safety standards (IEC 60601 series), and comparison to the predicate device's proven functionality and safety. The device's ability to irradiate blood effectively for its stated purpose is an established physical principle and was likely assumed to be met based on using the same core X-ray technology as the predicate, with increased power.

8. The sample size for the training set:

Not Applicable. This device does not use machine learning or AI models that require a "training set."

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Auqust 12, 2016

Best Theratronics Limited % Mr. Mike de van der Schueren Quality & Regulatory Manager 413 March Road Ottawa, Ontario K2K 0E4 CANADA

Re: K161324 Trade/Device Name: Raycell Mk2 Regulation Number: None Regulatory Class: Unclassified Product Code: MOT Dated: August 4. 2016 Received: August 8, 2016

Dear Mr. de van der Schueren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv vours

Michael D. O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161324

Device Name Raycell Mk2

Indications for Use (Describe)

The Raycell X-ray Blood Irradiator is also intended for use in the irradiation of intra-operatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY

Date Summary Prepared	May 6, 2016
Submitted by	Best Theratronics413 March RoadOttawa, Ontario K2K 0E4CanadaTel. (613) 591-2100Fax. (613) 592-5680
Contact Person	Mr. Mike de van der SchuerenQuality & Regulatory Manager
Trade Name	Raycell Mk2
Common Name	Raycell X-Ray Blood Irradiator
Classification Name	Blood irradiators have not been classified
Legally Marketed Predicate Device	Raycell (K051065)
Device Classification	None
Product Code	90 MOT

Description of Device

Intended Use of Device

The Raycell X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease. This is the same intended use as previously cleared for the Raycell X-ray Blood Irradiator, (K051065).

The intended use of the modified device, as described in the labeling, has not changed as a result of the modifications.

Summary of Technological Characteristics

The Raycell is substantially equivalent to the predicate device (K051065).

The change to the Raycell design is to create a unit with increased capacity using the existing design. The same x-ray tubes and high voltage generators are used in the new Ravcell unit, but at a 25% higher power (4kW instead of 3.2kW on the predicate). There are no changes to the control system software from the predicate design.

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Image /page/4/Picture/0 description: The image shows the logo for Best Theratronics. The word "Best" is written in a stylized, cursive font in a dark blue color. Below "Best" is the word "Theratronics" in a green, sans-serif font. A registered trademark symbol is located to the right of the word "Best".

Following is a list of changes to the new design:

Canister Size

The new device is available in either a 3.5L sample canister configuration or a smaller 2L sample canister configuration. The predicate device was only available in a 1.5L configuration.

Sliding Drawer

A combination of a pivoting outer door and a hinged inner door was replaced by a sliding drawer arrangement. External radiation fields have been decreased and manufacturability aspects have been improved.

All electrical interlocks have been maintained. A new electro-mechanical safety interlock has been added, which prevents operators from opening the sample drawer when x-rays are generated. This was done to compensate for elimination of the outer door present in the previous design.

Shielded Irradiation Chamber

The volume inside the lead shielded chamber has increased to accommodate the 3.5L sample canister. The chamber has also been modified using the same lead shielding to improve manufacturability and access for service and maintenance. New access panels have been added and are interlocked electro-mechanically (same as predicate device). External radiation fields have decreased from the predicate design.

Digital Traceability

Optional digital traceability is available as a database to be used with the Raycell to eliminate the need for manually recording data and reducing human error. This consists of a bar code reader to record and store data from the blood baq and view it on a separate touch screen computer. It is able to retrieve cycle times from the Raycell, which allows the user to keep a history of the radiation cycles completed. It has no impact on radiation times or dose delivered and is not useable as a stand-alone product.

It is not intended to determine the suitability of donors and/or the release of blood or blood components for transfusion or further manufacture.

It does not change the intended use of the previously cleared Raycell X-ray Blood Irradiator.

Safety & Effectiveness

The safety of the Raycell is equivalent or better than the predicate device.

In terms of safety, the Raycell is designed to comply with

. IEC 60601-1-2: Edition 3.0 2007-03 Medical electrical equipment – Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (Appendix L)
. IEC 60601-1: Edition 3.0 2005 + CORR. 1 (2006) + CORR. 2 (2007) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Appendix M)

The performance of the device was tested against a set of functional specifications in an environment that simulated, as much as possible, the actual operating environment. Validation testing demonstrated that the device is as safe and effective as the predicate device.

Regulation Number and Section

N/A